Doctor of Philosophy in mathematics and physics, Head of Product Portfolio, European Medicines Agency (2020-present), Head of Regulatory Affairs (ad interim), European Medicines Agency (2020), Head of Regulatory Affairs, European Medicines Agency (2014-2020), Regulatory Affairs Adviser, European Medicines Agency (2009-2014), Scientific Administrator, European Medicines Agency (2005-2009), National expert on Secondment, Scientific Administrator, European Medicines Agency (2004-2005), Scientific Administrator, Infarmed, Lisbon, Portugal (2000-2004), Post-graduation degree in Economic Evaluation of Medicines, Instituto Superior de Economia e Gestão e Faculdade de Farmácia da, Degree in Pharmaceutical sciences, Faculdade de Farmácia da, Head of Quality and Safety of Medicines, European Medicines Agency (2020-present), Head of Procedure Management, European Medicines Agency (2013-present), Head of Evaluation Procedures B (ad interim), European Medicines Agency (2017-2018), Head of Chemicals, European Medicines Agency (2012-2013), Scientific Administrator, European Medicines Agency (2002-2012), New Products Development Manager, Famar SA (2000-2002). The clinical data have been submitted by pharmaceutical companies to support their marketing applications for human medicines under the centralised procedure and have been assessed by the Committee for Human Medicinal Products (CHMP). It provides leadership for the Agency's pharmacovigilance system. EMA is a networking organisation whose activities involve … Bachelor of Medicine, Surgery and Obstetrics, and Bachelor of Arts, Head of Signal and Incident Management, European Medicines Agency (2016-2020), Head of Signal Management, European Medicines Agency (2013-2016), Head of Signal Detection and Data Analysis, European Medicines Agency (2012-2013), Head of Signal Detection and Data Analysis (ad interim), European Medicines Agency (2011-2012), Scientific Administrator, European Medicines Agency (2010-2011), Associate Director Global Medical Affairs Immunology, UCB Pharma S.A., Brussels, Belgium (2006-2010), Project Manager, Cardiovascular, Johnson & Johnson Medical, Waterloo, Belgium (2002-2005), Medical Reviewer, Quintiles / Janssen Pharmaceutica N.V., Beerse, Belgium (2000-2002), Clinical Research Associate, Quintiles, Sofia, Bulgaria (1998-2000), Physician, Military Service, Bulgaria (1997-1998), Scientific Administrator, European Medicines Agency (2008-2020), Affiliate Safety Representative / Drug Safety Manager, Abbott Laboratories, Amadora, Portugal (2004-2008), Regulatory Affairs Trainee, GlaxoSmithKline, Algés, Portugal (2003-2004), Degree in Pharmaceutical Sciences, Faculdade de Farmácia da, Head of Committees and Quality Assurance, European Medicines Agency (2020-present), Head of Evaluation Procedures B, European Medicines Agency (2018-2020), Head of Telematics and Governance Office, European Medicines Agency (2017-2018), Head of Telematics Office, European Medicines Agency (2015-2017), Head of Rheumatology, Respiratory, Gastroenterology and Immunology (ad interim), European Medicines Agency (2013-2015), Scientific Administrator, European Medicines Agency (2008-2013), European Regulatory Affairs, Schering-Plough Europe, Brussels, Belgium (2000-2008). EMA’s human medicines committee (CHMP) has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation. Doctor of Philosophy in molecular and cell biology, Head of Labeling, European Medicines Agency (2020-present), Head of Labeling Review and Standards Office, European Medicines Agency (2014-2020), Responsible for the Quality Review of Documents Group Secretariat, European Medicines Agency (2004-2009), Administrator, European Medicines Agency (2001-2004), Research Assistant, Ministry of Interior and Public Administration, Athens, Greece (1994-1995). EMA will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines. The EMA's work benefits: 1. patients 2. healthcare professionals 3. academics 4. pharmaceutical companies 5. medicine developers 6. health policymakers.Through its scientific guidelines, scientific advice programme and incentives, it facilitates research into new medicines and encourages development, thereby translating progress in medical science into medicines with real health benefits for patients. The Division maintains close contact with other decision-makers in healthcare and with international partners, in conjunction with the Agency's international-affairs function. The EMA's work benefits: 1. patients 2. healthcare professionals 3. academics 4. pharmaceutical companies 5. medicine developers 6. health policymakers.Through its scientific guidelines, scientific advice programme and incentives, it facilitates research into new medicines and encourages development, thereby translating progress in medical science into medicines with real health benefits for patients. EMA is listed in the World's largest and most authoritative dictionary database of abbreviations and acronyms The Free Dictionary Doctor of Philosophy in biochemistry / molecular biology, Doctor of Pharmacy, University of Nancy, France (1992), Masters degree in biochemistry, University of Nancy, France (1990), Scientific Adviser on Human Medicines, European Medicines Agency (2020-present), Deputy Head of Product Development Scientific Support, European Medicines Agency (2015-2020), Principal Scientific Administrator, European Medicines Agency (1999-2004), Board-certified physician for pharmacology and toxicology, Bavarian Chamber of Physicians, Munich, Germany (1994). At the European Medicines Agency (EMA), we believe that great young minds add important value to our work. rules governing medicinal products in the EU, Ethical use of animals in medicine testing, Medicines for use outside EU (Article 58), Scientific advice and protocol assistance. 15/12/2020. In 2019, EMA recommended 66 medicines for marketing authorisation. EMA’s human medicines committee (CHMP) has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation. The entry pages on these topics provide an overview of the topic and direct users to relevant content in the product lifecycle sections. Master's degree in European regulatory affairs, Head of Meeting Secretariat, European Medicines Agency (2020-present), Head of Working Parties Secretariat (ad interim), European Medicines Agency (2015-2020), Scientific Administrator, European Medicines Agency (2009-2015), Regulatory Affairs Manager, Schering-Plough, Brussels, Belgium (2006-2009), Regulatory Affairs Officer, Baxter, Brussels, Belgium (2003-2006), Trainee, Baxter, Nivelles, Belgium (2003), Deputy Head of Packaging, Schering AG, Lys-lez-Lannoy, France (2000-2003), Deputy Head of Packaging, Laboratoires UPSA, Agen, France (1997-2000), Project team manager, Laboratoires UPSA, Agen, France (1995-1997), Trainee, Laboratoires UPSA, Agen, France (1994-1995), Trainee, Roussel-Uclaf, Paris, France (1991-1992), Hospital pharmacy trainee, Central University Hospitals, Nancy, France (1990-1991), Masters in regulatory affairs and health economy, University of Lille/Paris/Lyon, France (2003), Masters in pharmaceutical manufacturing, University of Bordeaux, France (1994), Doctor of pharmacy specialising in industry, University of Nancy/Bordeaux, France (1996), Head of Procedures, European Medicines Agency (2020-present), Head of Evaluation Procedures D, European Medicines Agency (2014-2020), Scientific Administrator, European Medicines Agency (2006-2014), Business Intelligence Analyst, AstraZeneca, Madrid, Spain (2004-2006), Master in management of pharmaceutical and healthcare industries, Instituto de Empresa, Madrid, Spain (2004). Dr. Wolfgang Wordarg, pulmonologist and former head of a public health department, and Dr. Michael Yeadon, ex-Pfizer research director for respiratory diseases, petitioned the EMA, the European Medicines Agency, on December 1, 2020, to immediately stop clinical trials of the Corona vaccines. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. It provides the secretariat to all EMA committees and working parties that support EMA's work on human medicines. EMA Pharmaceuticals presents SMARTSEAL, a powerful covert anti-counterfeiting feature, enabling the easy track & trace of the individual container through RFID technology. Masters degree in European judicial studies, Law degree, Democritean University of Thrace, Komotini, Greece (1993), Head of Regulatory Affairs (2020-present), Head of Evaluation Procedures F, European Medicines Agency (2017-2020), Head of Evaluation Procedures F (ad interim), European Medicines Agency (2017), Regulatory Affairs Officer, European Medicines Agency (2009-2017), Regulatory Intelligence Officer, Novartis Pharma (2008-2009), Regulatory Affairs Executive, Leo Pharma (2002-2008). Doctor of Philosophy in clinical research, Head of Scientific Evidence Generation, European Medicines Agency (2020-present), Head of Product Development Scientific Support, European Medicines Agency (2016-2020), Head of Scientific and Regulatory Management, European Medicines Agency (2013-2016), Head of Rheumatology, Respiratory, Gastroenterology and Immunology, European Medicines Agency (2009-2013), Scientific Administrator, European Medicines Agency (2007-2009), Regulatory Project Manager, Roche Products Ltd., Welwyn Garden City, United Kingdom (2003-2006), Drug Regulatory Affairs Manager, Hoffmann-La Roche AG, Grenzach-Wyhlen, Germany (1999-2003), Drug Regulatory Affairs Manager, medac AG, Hamburg, Germany (1998-1999), Scientific Assistant, Institute for Pharmaceutical Technology and Biopharmaceutics, Münster, Germany (1994-1997), Head of Scientific Advice, European Medicines Agency (2020-present), ]Head of Evaluation Procedures C, European Medicines Agency (2014-present), Primary care physician, Ioannina, Greece (1998-2001). This section of the website provides information on the regulation of medicines for human use in the European Union (EU). EMA accepts Sanofi’s submission for avalglucosidase alfa in Pompe disease. Posted on: 25 September 2019; By: Shalini.Sharma; The Committee recommended granting a marketing authorisation for Xospata* (gilteritinib) for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. Human medicine European public assessment report (EPAR ... European Medicines Agency Domenico Scarlattilaan 6 1083 HS Amsterdam The ... EMA is in the process of making appropriate changes to this website. ... EMA approves the COVID- 19 vaccine(s) in questionboth governments of EU member states , The EMA’s human medicines committee said in a press release on 26 September 2019 that it was requesting marketing authorisation holders for human medicines to “test all products at risk … as a matter of precaution”. The European Medicines Agency (EMA) is a decentralised agency of the European Union, located in London. EMA is in the process of making appropriate changes to this website. If nitrosamines are detected in any of their medicines, manufacturers must inform authorities promptly, the EMA said. The EU Open Data Portal provides, via a metadata catalogue, a single point of access to data of the EU institutions, agencies and bodies for anyone to reuse. Doctor of Science in pharmaceutical analysis, Head of Therapies for Neurological and Psychiatric Disorders, European Medicines Agency (2020-present), Head of Central Nervous System and Ophthalmology, European Medicines Agency (2019-2020), Head of Central Nervous System and Ophthalmology (ad interim), European Medicines Agency (2018-2019), EMA product lead, Central Nervous System and Ophthalmology, European Medicines Agency (2013-2018), Clinical neurologist, University Hospital, Plovdiv, Bulgaria (2003-2008), Doctor of Philosophy (PhD) in Neurology and Pharmacoeconomics, Medical University, Plovdiv, Bulgaria (2007), Specialist in Neurology, University hospital, Plovdiv, Bulgaria (2007), Medical Doctor, Medical University, Sofia, Bulgaria (2001), Head of Endocrine and Cardiovascular Diseases, European Medicines Agency (2020-present), Head of Endocrinology, Metabolism and Cardiovascular, European Medicines Agency (2011-2020), Scientific Administrator, European Medicines Agency (2002-2011), European Clinical Pharmacology Coordinator, Lilly Clinical Development, Mont-Saint-Guibert, Belgium (2001-2002), Trainee, Eli Lilly, Fegersheim, France (1998-1999), Industrial Pharmacist (registered), Belgium (1999), Head of Therapies for Immune and Inflammatory Diseases, European Medicines Agency (2020-present), Head of Evaluation Procedures A, European Medicines Agency (2014-2020), Scientific Administrator, European Medicines Agency (2008-2014), European Regulatory Affairs Manager, Merck Serono, Geneva, Switzerland (2005-2008), European Regulatory Affairs Associate, Parexel, London, United Kingdom (2004-2005), International Regulatory Affairs Executive, GlaxoSmithKline, London, United Kingdom (2003-2004). , located in London EMA accepts Sanofi ’ s human medicines Division oversees human medicines the journey of diverse., Masters in regulatory affairs and pharmaceutical legislation, University of Lille, France ( ). 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